Impact of a Minimal Psychoeducational Intervention Versus Standard of Care on Anxiety Among Hospitalized COVID-19 Patients in Denmark: a Randomized Clinical Trial

INTRODUCTION Around 20% of people with COVID-19 becomes seriously ill with pneumonia and multi-organ failure, requiring hospital admission to relieve the symptoms and reduce mortality. To avoid any spreading of the virus, hospitalized COVID-19 patients are isolated. Thus, patients hospitalized with COVID-19 are limited in their social support and their only in-person contact is with healthcare staff in full personal protective equipment. Several studies highlight that isolation due to infection may have negative psychological implications. Moreover, Patients with confirmed or suspected COVID-19 may experience fear of the consequences of the infection. A high prevalence of persistent mental health problems has been found among patients during infectious disease outbreaks such as the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS). Researchers and policy makers have highlighted that the psychological impact of the COVID-19 pandemic must be recognized alongside the physical symptoms for all those affected. Moreover, evidence-based evaluations and mental health interventions targeting hospitalized COVID-19 patients and their relatives are at present lacking. If left untreated, these psychological symptoms may have long-term health effects on patients and require treatment adding to the cost burden of managing the illness.

OBJECTIVE The objective of this project is to test the efficacy of a minimal psychoeducational intervention versus standard of care at discharge for reducing symptoms of anxiety in hospitalized patients during the COVID-19 outbreak

METHODS Design This is a Randomized Controlled Trial (RCT) among hospitalized COVID-19 patients.

Hypothesis The primary hypothesis is that a minimal psychological intervention will reduce anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS) subscale for anxiety (HADS-A) by 1.5 points from baseline to follow-up 1 month after discharge from hospital. The estimated decrease in HADS-A is based on the clinically important difference found in patients with COPD and isolation studies.

Study population Patients will be recruited from the Department of Infectious Diseases and the COVID-19 isolation wards at Copenhagen University Hospital, Hvidovre; one of the major hospitals treating COVID-19 patients in Denmark.